Table 2. Objectives of Phase 1 oncology trials.
• Evaluate safety and tolerance |
• Determine dose-limiting toxicity |
• Define maximum tolerated dose |
• Define optimal biologically active dose |
• Determine dose and schedule for initial Phase 2 efficacy trials |
• Evaluate pharmacokinetics (ADME*) |
• Evaluate effects on molecular target or pathway |
• Observe for preliminary evidence of antitumour activity |
ADME, Absorption, distribution, metabolism, elimination.